Design & Development Flashcards
What is a medical device?
Any instrument, apparatus, appliance, software, implant, reagent, material or article intended by manufacturer alone or in combination for human beings for a medial purpose
When are medical devices used?
Disease
Disability
Replacement/modification of anatomy
In vitro examination
Control/support
Cleaning/disinfecting
What are 6 types of medical devices?
Implantable
Active - relies on a source of electrical energy
Active implantable
custom-made
software
accessory
What is in vitro diagnostics?
any medical device to be used in vitro for examination of specimens derived from human body
What are 4 times the in vitro diagnostics used?
Concerning a pathologicaly/physiological state
congenital abnormality
safety/ compatibility
monitor therapeutic measures
What are 4 key aspects of the in-vitro diagnostics regulation?
New classification system
changes to conformity assessment procedures
performance evaluation & clinical data requirements
changes to requirements to in-house manufacturing of IVDs
What are examples of medical devices?
TAVI valve
single port surgery
hip implant
minimally invasive GERD surgery
What are examples of ‘artificial organs’?
Artificial heart
cochlear implant
bioengineered kidney
What are the 4 classes of device classficiation?
I - wheelchairs, low risk
IIa - contact lenses, ECG machines - implied risk of malfunction
IIb - peripheral bare metal stent - truly implantable (minimal surgery)
III - orthopedic hip implant (traumatic surgery)
What 4 things do the classification of a device influence?
Pre-market requirements
conformity assessment route
clinical data requirements
post-market vigilance obligation
What are 4 key stakeholders in device devlopement?
Product end users
manufacturers
regulators
healthcare funders
What is design thinking?
design philosophy
What key design features will be critical for success
What is the HTA?
Process by which government will decide what is the most cost effective drug/device
What do essential requirements aim to ensure?
That medical devices are designed, manufactured & used such that unnecessary risks are avoided
What are 3 things needed for design controls?
Regulatory requirement
collection of ‘best practices’
compliance ensuring high safety & effectiveness
What are 5 challenges?
Philosophical Legacy
Evolution vs revolution
Image & reputation
‘suitably qualified person’
Software as medical device
What are 5 key considerations for medical devices?
Diverse materials
long-term tissue contact
tissue response
hard vs soft tissue implants
high-risk mucosa contacting
